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Eric F. Greenberg, a private attorney with a practice concentrated in representing FDA-regulated food companies and others.
Informational only, not legal advice

There are several truisms about food companies and documentation:

MORE DOCUMENTS THAN EVER
First, companies producing FDA-regulated foods these days are required to make and keep more documentation than ever, mostly due to the Food Safety Modernization Act of 2011. Companies are required to generate, for example, food safety plans with a hazard analysis and preventive controls, a supply chain program and a recall plan. Then, after setting up these systems, companies need to generate and keep documentation proving they are following the programs they established.
Also, companies who recall food should remember that they might have reporting obligations, within 24 hours of discovery, about food that might be a danger to health, via the Reportable Food Registry portal.

DOCUMENTS ARE NOT ENOUGH: ALSO TRAIN
Second, once you have set up those documented programs, don’t neglect to train your employees on what they require. This goes for recall plans as surely as any other aspect of your program. FDA inspectors think perty documents are fine, but they would rather see confirmation that your people have a thorough knowledge of what’s in them and operate under them all the time. Which leads to the third point…

DOCUMENTS ARE NOT ENOUGH: ALSO DO WHAT THE DOCUMENTS SAY
Third, for gosh sakes, be sure to follow your own procedures. It’s the easiest thing in the world for an FDA inspector to cite your company (that is, make an inspectional observation) for your failure to follow your own written procedures. There are a lot of interesting policy debates one could have about the wisdom or necessity of any particular detail of a company’s safety plan or preventive controls, but those debates really don’t matter if you said in your own SOP that you would check the temperature of your cake mix after baking, but didn’t do so.

DOCUMENTS AND RECALLS
Finally, documentation is relevant to recalls in at least two important senses. One is that the company will have in place the requisite recall plan, having thought through in advance the necessary steps to undertake or consider when problems arise. The value of preparing in advance cannot be underestimated, particularly because circumstances in which safety concerns arise or are suspected can be high-pressure, fluid, and even emotionally charged.
Second, of course, documentation of production can help a company identify causes or potential causes and define a limited scope for the affected product, and then identify the consignees who received the product within that scope. Without such documentation, the prospect exists that a company might decide its only reasonable option is to recall everything it’s made that is still out in commerce, which is often a very expensive and burdensome option.

Have more questions about documentation or would like to get in touch with the author? Contact ConnectFood.

About the Author:


Eric F. Greenberg is Principal Attorney of the law firm Eric F. Greenberg, P.C., with a practice concentrated in food and drug law, packaging law, and commercial litigation.

His food and drug work has included regulatory counseling, label and claims review, new product development, GRAS and food contact materials evaluations and clearances, negotiations with the U.S. Food and Drug Administration and state agencies, handling recalls, and defending enforcement actions.

In addition to his law practice, Eric is a member of the Adjunct Faculty of the Chicago-Kent College of Law, where he teaches Food and Drug Law and Administrative Law, and graduate and undergraduate Packaging Law and Regulation at California Polytechnic State University (CalPoly).

Eric wrote the book, Guide to Packaging Law, the Second Edition of which was published in October 2007. He serves as Legal Editor and monthly legal columnist for Packaging World Magazine. Eric has served as General Counsel of the Contract Packaging Association for over 15 years. His firm is based in Chicago and represents clients based all over the world.

This week was a historic week for the federal Food and Drug Administration (FDA). Three times since the signing of the Food Safety Modernization Act (FSMA) in 2011, FDA has used its new authority, i.e. new tools to prevent illness or injury from food. In 2012, FDA suspended the facility registration of Sunland, Inc. of Portales, New Mexico, a manufacturer of peanut butter. In 2013, FDA sent a Notification of Opportunity to Initiate a Voluntary Recall to Kasel Associates Industries, Inc., a manufacturer of pet treats. This week, FDA ordered a mandatory recall of kratom products from Triangle Pharmanaturals, LLC of Las Vegas, Nevada.

The FDA used its authority under FSMA to order a recall. This is a big deal. In all the history of food safety and the FDA, this is the first time the FDA has announced a mandatory recall. There have been thousands of recalls in FDA’s history, and before this week, every single recall has been voluntary and announced by the company.

What were FDA’s options before FSMA? Traditionally, FDA has followed up inspections with Form 483. Observations are detailed on Form 483, and the company must respond with corrective action to each observation. FDA has written soft letters, had phone conversations and sent email messages to communicate. Beyond communication and for more action, the FDA sends Warning Letters and can go to federal court to seek either an injunction to halt sale of product or an order for seizure of product. Product seizure can be taking product off store shelves or stopping finished product from entering commerce. Those are a lot of options! In the three cases stated above, FDA used many tactics to communicate and work with the companies, before getting to the last straw.

Case 1. Sunland peanut butter sold finished product containing Salmonella.
A little research on Sunland shows a long history of peanut butter recalls and FDA communication from 2009 to 2012. Just a year and a half after President Obama signed FSMA and four years before the food industry came under compliance and enforcement, the FDA exercised its new authority. For my readers who favor less government and less rules, look at what FDA did before pulling Sunland’s registration:

    1. 2007: Form 483 following inspection 10/25/2007
    2. 2009: Form 483 following inspection 3/10/2009
    3. 2010: Form 483 following inspection 9/23/2010
    4. 2011: Form 483 following inspection 3/25/2011
    5. 2012: Form 483 following inspection 10/29/2012

For the 2012 inspection, FDA was on-site for one month and listed the details of ten observations. Given authority under FSMA, FDA was able to stop production of Salmonella-laden peanut butter. The Centers for Disease Control and Prevention (CDC) reported the Salmonella outbreak from Sunland peanut butter covered 20 states and was responsible for 42 cases. Children under 10 were 61% of the cases, and 28% of cases were hospitalized. We know that diagnosed and reported illnesses represent a small portion of all persons with illness from an outbreak. Dozens of companies using peanut butter in their products went through subsequent recalls because of the peanut butter recall. I know, because it was my job to follow recalls and post them to ConnectFood’s Twitter.

Case 2. Kasel dog treats recalled after Salmonella found.
FDA has authority for enforcement and compliance over animal food. In February of 2013 Kasel was manufacturing dog treats and was re-inspected. In a 2012 inspection, Salmonella was found in the dog treats, in the processing environment, and on food contact surfaces. FDA inspectors cited problems with Kasel’s Good Manufacturing Practices including building repair, pest control and cleaning and sanitizing procedures. The dog treats had either a one-year or two-year expiration date. Kasel was given two days to initiate a voluntary recall after receiving FDA’s Notification of Opportunity to Initiate a Voluntary Recall, and Kasel complied by announcing a voluntary recall on February 19, 2013. Here’s my favorite sentence from the Notification: If you do not voluntarily cease distribution and conduct a recall in the time and manner described in this section, FDA may, by order, require you to immediately cease distribution of the affected pet treats. Fast-forward to 2018. FDA is rigorously inspecting animal food manufacturers, and we have seen a wave of pet food recalls [author’s note: choose Animal Health for from the drop down menu of recall categories], primarily of raw pet food.

Case 3. Triangle Pharmanaturals’ kratom products contain Salmonella.
Remember all those options available to the FDA? It seems the FDA used them and got no response from the company in return. FDA sent Triangle Pharmanauturals a Notification of Opportunity to Initiate a Voluntary Recall with no response from the company. All companies in the past which have received this letter from the FDA have followed up with a voluntary recall, because this is the first company which has not! This is the evidence I have gathered against Triangle Pharmanaturals. There is currently (April 2018) a multi-state outbreak of Salmonella. During interviews in March of people ill from Salmonella, when specifically asked, 40 of 55 reported consuming kratom before getting sick. Salmonella has been isolated twice from Triangle Pharmanaturals’ products by the state of Oregon and four times by FDA. Triangle Pharmanaturals’ competitors have recalled their kratom products. As I am writing this, I received updated recall information to include 38 states and 132 confirmed cases.

These three companies have in common that their products contained Salmonella. To me as a microbiologist, that is interesting. More importantly, their company names are forever tied to the history of FDA in the fight of foodborne illness. Personally, I am thankful for the work of the FDA and CDC.

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About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd